Actively Recruiting
Toripalimab in Combination With Standard Treatment for Human Papillomavirus (HPV) Positive Throat Cancer
Led by University of Chicago · Updated on 2026-02-06
30
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center phase 2 study of to test how well the combination of toripalimab with chemotherapy followed by TORS or risk and response stratified de-escalated (chemo)radiotherapy works in patients with in HPV16+ locoregionally advanced oropharyngeal cancer (OPC).
CONDITIONS
Official Title
Toripalimab in Combination With Standard Treatment for Human Papillomavirus (HPV) Positive Throat Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed HPV16-positive head and neck squamous cell carcinoma of the oropharynx
- HPV16 subtype confirmed by p16 IHC positivity and HPV PCR
- Age 18 years or older
- AJCC (8th edition) stage N1 (if solitary lymph node \u22653cm), N2-N3 nodal disease, or T3-T4 primary tumor
- Measurable disease by RECIST 1.1 criteria
- No prior radiation or chemotherapy for head and neck cancer
- No complete surgical resection for head and neck cancer within 8 weeks before enrollment, except biopsy with residual disease
- ECOG performance status 0-1
- Normal organ function per protocol
- Candidate for cisplatin treatment as determined by physician
- Signed informed consent form
- Negative pregnancy test for women of childbearing potential within 24 hours before treatment
- Women must not be breastfeeding
- Women of childbearing potential and men with partners must agree to use contraception during treatment
You will not qualify if you...
- Distant metastatic disease (M1)
- Non-HPV16 subtype
- Unidentifiable primary tumor site
- Medical illnesses limiting therapy tolerance or survival, including active infection, immunodeficiency, symptomatic heart failure, pulmonary dysfunction, cardiomyopathy, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- Low risk N1 disease (single lymph node <3cm)
- Active autoimmune or inflammatory disorders requiring immunosuppressive therapy (except low-dose prednisone \u2264 10mg)
- Use of immunosuppressive doses of systemic steroids or medications within 14 days prior to treatment
- Chronic immunosuppressive medication use within 6 months prior to treatment
- Active autoimmune disease requiring systemic treatment in past 2 years
- Prior severe allergic reaction to immunoglobulin or antibody administration
- Use of herbal remedies with immune-stimulating effects within 28 days before treatment
- Prior surgical therapy other than biopsy or organ-sparing procedures
- Treatment with other investigational agents
- Systemic anti-cancer treatment within last 8 weeks
- Additional progressing malignancy requiring active treatment, except certain skin cancers or in situ cervical cancer
- Active non-infectious pneumonitis
- Active hepatitis B or C infection
- Receipt of live vaccine within 28 days before study therapy start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
C
Cancer Trials Intake
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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